Putting Together the Pieces on FDA’s Social Media Guidance

When the Food and Drug Administration (FDA or the Agency) held a public hearing on the use of the internet and social media to promote regulated products, many in the industry were hopeful we would
…

When the Food and Drug Administration (FDA or the Agency) held a public hearing on the use of the internet and social media to promote regulated products, many in the industry were hopeful we would soon have clear direction on how to evolve our communications for the digital age. Nearly five years later, we’re still waiting for that guidance to be complete. Just recently, FDA released two draft guidance documents, the latest in a series on various elements of digital engagement bringing the total to four out of an expected five.

The last piece of draft guidance the Agency has committed to releasing this year (though it has already missed the July 9 deadline set forth in the 2012 FDA Safety and Innovation Act) is related to the use of links in product promotional content in social media.

A number of industry commentators and media outlets have already covered the details of the latest FDA social media guidance documents. Rather than reiterate the same points about these two, we’ve taken a step back and pulled out the key pieces from all four to help guide clients in the drug and device industries as they continue to navigate the new media landscape.

Transcript

2.
The last piece of draft guidance the Agency has committed to releasing this year (though it has already
missed the July 9 deadline set forth in the 2012 FDA Safety and Innovation Act) is related to the use of
links in product promotional content in social media.
A number of industry commentators and media outlets have already covered the details of the latest
FDA social media guidance documents. Rather than reiterate the same points about these two, we’ve
taken a step back and pulled out the key pieces from all four to help guide clients in the drug and
device industries as they continue to navigate the new media landscape.
User-Generated =
Outside of Company Control
First,
Do Not Mislead
 Responding to Unsolicited Requests for
Off-Label Information (Dec. 2011)
 Fulfilling Regulatory Requirements for
Postmarketing Submission of Interactive
Promotional Media (Jan. 2014)
 Correcting Independent Third-Party
Misinformation About Prescription Drugs and
Medical Devices (June 2014)
 Internet/Social Media Platforms with
Character Space Limitations (June 2014)
When the Food and Drug Administration (FDA or the Agency) held a public hearing on the use of the
internet and social media to promote regulated products, many in the industry were hopeful we
would soon have clear direction on how to evolve our communications for the digital age. Nearly five
years later, we’re still waiting for that guidance to be complete. Just recently, FDA released two draft
guidance documents, the latest in a series on various elements of digital engagement bringing the
total to four out of an expected five. Here’s what we’ve got so far:
FDA uses the term “non-misleading” 20 times in these
four draft guidance documents. “Accurate” comes up
22 times. Clearly, this is a guiding principle for the
Agency, and you’ll notice each one of the below points
is constructed with it as its ultimate goal.
While much is spelled out specifically in these
documents, there is a lot that remains up for
interpretation. When in doubt, a good place to start is
by asking: Could this be considered misleading? If
the answer is anything but "No," don’t do it.
One of the most important things the Agency does
in its guidance thus far is to clarify what content
companies are responsible for and, perhaps more
importantly, what they are not responsible for.
This is one of the biggest issues keeping most
drug and device makers on the sidelines of social
media engagement. FDA has, in three of its four
draft guidance documents, made some important
statements about company responsibility:
 Company is not responsible for UGC that it does
not control or influence

3.
 Company is responsible for content created by
employees, agencies, and contractors acting on
behalf of the company (including paid
influencers and spokespeople)
 Company is not responsible to monitor and
correct information online about its products
 If a company decides to correct information
online about its products, it is not responsible for
correcting all content on that site, just the clearly
defined section it is correcting
 Once a company corrects information online
about its products, it is not responsible for
monitoring the site for further comments or
updates
One important thing to keep in mind regarding
company responsibility and UGC that isn’t mentioned
in the draft guidance is the reporting of adverse
events. While a company may not be held responsible
for the content of the post, any time a company
employee or contractor comes across an adverse
event report online, it must be reported to FDA in
accordance with company policies. This is the other
big issue keeping the industry from more active
engagement online and one that isn’t going to change.
There are Some Exceptions
to the Standard Procedures
FDA’s regulation of social media stems from its
authority over product labeling and advertising.
Therefore, barring exceptions, the current rules for
those communications, such as balancing risk and
benefit, apply in social media channels as well.
The FDA social media draft guidance contains a
few such exceptions, including:
 Correcting Misinformation: The Agency
recognizes that user-generated content (UGC)
often includes incorrect information about
regulated products. It also knows that the
manufacturers of those products have the
most incentive to correct that information. In
the interest of encouraging non-misleading
communications, the Agency stated in its recent
guidance that companies don’t need to adhere
to traditional guidelines when correcting such
misinformation.
 Responding to Unsolicited Requests for
Off-label Information: Just as manufacturers
have greater incentive to correct misinformation
about their products, FDA recognizes that they
also know more about experimental uses of
those products than anyone else. In the event
that someone asks about an unapproved use
of its product, the Agency has said it will not
object to a company providing that information
(traditionally a no-no). Requirements include
the information being non-misleading, narrowly
tailored to the question asked, private between
the company and individual, and from the
medical department and not marketing or sales.

4.
-
No Shortcuts for
Short Form
While this one wasn’t a surprise, there were some in the
industry still holding out hope for product-promotional
tweets. Some rules just don’t have exceptions.
In its latest round of draft guidance, the Agency
explicitly addressed the use of character-limited
platforms (Twitter and paid search) for promoting
regulated products. In opening the door for product
promotional tweets by outlining the requirements
and giving an example, FDA social media guidance
has left little room for saying anything beyond the
name, indication, important risk information, and a
link to the full important safety information (ISI).
Even in the Agency’s example with a fictional drug
with a short name and straightforward indication and
risks, there were only 6 characters
remaining for any kind of promotional messaging.
While it would have been nice to see some kind of
innovative solution to communicating fair balance in
short-form, it isn’t surprising not to see one.
While there are certainly other insights that can be
applied from the Agency’s draft social media guidance,
these are the ones most likely to have an impact on
future social media engagement by the industry. We’re
likely to see some additions to this list following the
release of the final social media guidance document
on the use of links. Whether it beats the July 9 deadline
or not, just don’t bet on any major surprises and rest
assured you’ll see “non-misleading” a time or ten.
For more information, please contact:
Josh Baldwin
646-500 7830
josh.baldwin@mslgroup.com